Screening for GDM in Women With PCOS and Controls

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome; Gestational Diabetes Mellitus
• Interventions: Other: OGTT by randomization; Other: OGTT by indication

• Registration Number: NCT02183558
• Lead Sponsor: Odense University Hospital

Brief Summary

Women with polycystic ovary syndrome (PCOS) are often insulin resistant. During pregnancy, insulin sensitivity decreases. The investigators examine glucose metabolism during oral glucose tolerance test and the incidense of gestational diabetes mellitus in a prospective cohort of pregnant women with PCOS and controls.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-09
• Study Completion: 2014-06
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-08
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-23
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2500

Inclusion Criteria

• Pregnancy achieved during 2010-2012
• Residents of the municipality of Odense

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Exclusion Criteria

• Moving from Odense during pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OGTT by randomization	OGTT by randomization	Women without risk factors for GDM are offered OGTT in gestational week 28
OGTT by indication	OGTT by indication	Women with risk factors for OGTT are offered diagnostic 2 hour OGTT in pregnancy week 28

Primary Outcome Measures

Name	Time	Method
Gestational Diabetes Mellitus	Gestational week 28	Gestational diabetes mellitus is diagnosed by 2 hour 75 gram oral glucose tolerance test in gestational week 28
Gestational diabetes mellitus	2 years	Gestational diabetes mellitus diagnosed by oral glucose tolerance test in gestational week 28 in women with and without risk factors for gestational diabetes mellitus.

Secondary Outcome Measures

Name	Time	Method
Anthropometric measures in offspring	At birth	The association between blood glucose values and anthropometric measures (birth length, weight and abdominal circumference) at birth in the offspring is investigated

Trial Locations

Locations (1)

OdenseUH; 🇩🇰 Odense, Denmark